MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS 6.5 X 60MM; BONE FIXATION PLATE

Model Number	SCREW, CANCELLOUS 6.5 X 60MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/22/2024, it was reported by an arthrex subsidiary employee via email that an ar-13280-60 cancellous screw broke in the patient.This was discovered during an osteotomy procedure on (b)(6) 2024.Additional information received on 8/1/2024: the broken screw fragments were not removed.The case was completed using a new plate and screw.The case was not delayed, and additional anesthesia was not necessary.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation was confirmed based on foto parafusos.Jpg, where the broke screw was displayed next to two more screws and a plate.No allegation against the other device was received.Evaluation of the customer's photograph of an alleged ar-13280-60 cancellous screw, titanium, 6.5 x 60 mm attached to the complaint: where three screws and a plate are displayed.It was observed that one screw looked broken off, missing a significant piece of the screw.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) of the reported failure can be user error, such as misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.

• Brand Name: SCREW, CANCELLOUS 6.5 X 60MM
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20003679
• Report Number: 1220246-2024-07195
• Device Sequence Number: 17995840
• Product Code: HRS
• UDI-Device Identifier: 00888867010581
• UDI-Public: 00888867010581
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: SCREW, CANCELLOUS 6.5 X 60MM
• Device Catalogue Number: AR-13280-60
• Device Lot Number: 13482613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown